80 Participants Needed

OCT-Guided Phototherapeutic Keratectomy for Corneal Opacity

HM
DR
Overseen ByDenny Romfh, OD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve vision for individuals with corneal opacities, or cloudy spots on the front of their eyes. Using a special machine called OCT (Optical Coherence Tomography), doctors can guide a laser more precisely to remove these cloudy areas. This procedure, known as OCT-guided laser phototherapeutic keratectomy, acts like a GPS for eye surgery, ensuring precise treatment. Individuals with vision problems primarily due to these cloudy spots, rather than other eye issues like cataracts or glaucoma, might be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment precision and outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that OCT-guided laser phototherapeutic keratectomy is safe for corneal opacity treatment?

Research has shown that OCT-guided laser treatment for corneal problems is generally safe. This procedure can effectively reduce or remove corneal scars, leading to clearer vision.

OCT-guided methods use imaging to direct the laser, enhancing accuracy. This precision helps protect surrounding tissues from damage. Patients have reported that the treatment is well-tolerated, with no major side effects noted in studies.

Overall, evidence suggests that this method is a safe option for those with corneal clouding.12345

Why are researchers excited about this trial?

Unlike the standard treatments for corneal opacity, which often include traditional phototherapeutic keratectomy (PTK) or corneal transplantation, the OCT-guided phototherapeutic keratectomy uses advanced imaging technology to guide the laser surgery more precisely. This technique allows surgeons to accurately target the affected areas of the cornea, potentially reducing the risk of removing too much tissue and improving visual outcomes. Researchers are excited about this method because it could lead to faster recovery times and fewer complications, offering a more effective and safer alternative for patients with corneal opacity.

What evidence suggests that OCT-guided laser phototherapeutic keratectomy is effective for corneal opacity?

Research has shown that OCT-guided laser treatment, which participants in this trial will receive, can effectively improve vision by treating corneal opacities. This method uses advanced imaging to guide the laser, allowing for more precise removal of scarred tissue. Studies have found that patients who underwent this procedure often experienced better vision and consistent results. Long-term evidence suggests that the benefits of the treatment endure, providing ongoing improvements in vision. These findings support OCT-guided laser treatment as a reliable option for those with cloudy vision due to corneal opacity.13678

Who Is on the Research Team?

DH

David Huang, MD, PhD

Principal Investigator

Casey Eye Institute, Oregon Health & Science University

Are You a Good Fit for This Trial?

This trial is for individuals with vision problems due to superficial corneal opacities and irregularities that can be treated with PTK, leaving at least 250 µm of the cornea. It's not suitable for those who can't stay still for OCT imaging, commit to follow-up visits, have deep corneal issues, or other eye conditions like cataracts or glaucoma.

Inclusion Criteria

My vision issues can potentially be corrected by a specific eye surgery.

Exclusion Criteria

I have an eye condition that could affect my vision after surgery.
Inability to maintain stable fixation for OCT imaging
Inability to commit to required visits to complete the study
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

OCT is assisting in surgery guidance for phototherapeutic keratectomy (PTK) to treat corneal opacities

1 day
1 visit (in-person)

Follow-up

Participants are monitored for improvement in visual acuity and other outcomes post-procedure

12 months
Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • OCT-guided laser phototherapeutic keratectomy
Trial Overview The study tests if using OCT to guide laser settings improves vision in patients undergoing phototherapeutic keratectomy (PTK) for removing scars and defects on the front part of the cornea.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention

OCT-guided laser phototherapeutic keratectomy is already approved in United States for the following indications:

🇺🇸
Approved in United States as Phototherapeutic Keratectomy for:

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Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Published Research Related to This Trial

Custom phototherapeutic keratectomy (CPK) is a safe and effective treatment for highly aberrated eyes, with 88% of patients achieving 20/30 vision or better after 1 year, indicating significant improvement in visual acuity.
The procedure showed no cases of corneal ectasia, highlighting its safety as a surgical alternative to more invasive options like penetrating keratoplasty.
One-year follow-up of custom phototherapeutic keratectomy.Vinciguerra, P., Camesasca, FI.[2022]
In a study of 23 eyes from 21 patients, FD-OCT-guided phototherapeutic keratectomy (PTK) combined with photorefractive keratectomy (PRK) significantly improved uncorrected visual acuity (UCVA) from a mean of 0.79 to 0.45 and best spectacle-corrected visual acuity (BSCVA) from 0.57 to 0.28, indicating effective treatment for anterior corneal scarring.
The procedure demonstrated safety with no complications reported, and significant improvements in corneal topographic indices, suggesting enhanced corneal surface regularity and symmetry post-treatment.
Fourier-domain optical coherence tomography-guided phototherapeutic keratectomy for the treatment of anterior corneal scarring.Yang, YL., Jian, Q., Liu, B., et al.[2020]
In a study of 60 patients undergoing OCT-guided transepithelial phototherapeutic keratectomy (PTK) for anterior corneal scarring, best spectacle-corrected visual acuity (BSCVA) significantly improved from a mean of 0.77 logMAR preoperatively to 0.34 logMAR postoperatively over an average follow-up of 41 weeks.
The procedure also resulted in significant improvements in corneal topography indices, indicating effective treatment of corneal scarring, with only a small number of patients requiring further surgical intervention.
Long-term outcomes of optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring.Rush, SW., Matulich, J., Rush, RB.[2022]

Citations

Optical Coherence Tomography-Guided Transepithelial ...To report the outcomes of optical coherence tomography- (OCT-) guided transepithelial phototherapeutic keratectomy (PTK) for central corneal ...
Optical Coherence Tomography Guided Transepithelial ...The primary goal of the trial is to determine the efficacy of the OCT-guided PTK treatment of corneal opacities. During the course of the trial, we will ...
Optical Coherence Tomography–Guided Transepithelial ...To report the visual and anatomic outcomes of a novel technique for the management of anterior corneal scarring using optical coherence tomography ...
OCT-guided transepithelial PTK effective for anterior ...This prospective study found that OCT-guided transepithelial phototherapeutic keratectomy (PTK) using a dual ablation excimer laser profile can provide ...
Long-term outcomes of optical coherence tomography ...Conclusions The OCT-guided transepithelial PTK technique described in this study can deliver positive long-term results and predictable refractive outcomes in ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33215001/
Fourier-domain optical coherence tomography-guided ...Conclusion: FD-OCT-guided PTK combined with PRK is safe and effective for the treatment of anterior corneal scarring by eliminating or reducing ...
OCT-Guided Phototherapeutic Keratectomy for Corneal ...Research shows that phototherapeutic keratectomy (PTK), including OCT-guided versions, is generally safe for treating various corneal conditions, such as ...
Optical Coherence Tomography Guided Transepithelial ...The purpose of this study is to determine whether OCT-guided settings for the lasers used for removal of corneal scars and other partial- ...
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